Related Expert's Opinion

By Raqiyyah R. Pippins
Kelley Drye & Warren LLP

Last year, we detailed targeted FDA enforcement activity forewarning of increased FDA scrutiny of personal care products. An overview of 2012 FDA enforcement activity reflects FDA’s efforts to further distinguish cosmetic products from drugs and reestablish its authority over the marketing of personal care products.

FDA Action Picked Up

For the purposes of this article, “personal care products” are defined to include any product that is topically applied to improve a person’s appearance. Importantly, “personal care products” has no legal definition, but is commonly used to refer to a class of cosmetics and nonprescription drugs typically used by consumers to enhance (and then maintain) their appearance. The Federal Food Drug and Cosmetic Act (FDCA) grants FDA the authority to regulate a number of products, including all cosmetic and non-prescription drug products destined for the U.S. market.

As noted in last year's update, a personal care product’s regulatory classification can deeply impact the regulatory standards governing the product’s manufacturing, marketing and labeling. In 2011 FDA hinted at its intent to more closely scrutinize the classification of personal care products through several warning letters alleging that the labeling for certain personal care products marketed as cosmetics contained claims or ingredient statements that caused the products to be unapproved drugs under the FDCA. In 2012, FDA reinforced its intent to further distinguish “cosmetic” claims from those FDA has reserved for drugs through targeted letters to companies marketing products with claims regarding anti-aging skin care benefits, hair restoration, and scar removal.

Anti-aging Claims

Anti-aging claims have been the subject of increasing FDA scrutiny. In 2012, FDA put teeth to its position regarding anti-aging claims, by sending several warning letters to companies touting anti-aging benefits in advertising for products marketed as cosmetic products, alleging that the claims caused the products to be unapproved drugs. Specifically FDA alleged that claims that a product can “rebuild collagen,” “repair the structural damage that…causes… wrinkles,” “reduce [the] depth of wrinkles,” “help repair aged skin while preventing future damage,” and “help[ ] stimulate circulation in the under eye area, thus reducing or eliminating… ‘Dark Circles’” indicate that such products are “intended to affect the structure or function of the human body, rendering them drugs under the Act.”

The letters also indicate FDA’s position that comparing a personal care product to drugs or medical procedures may be viewed by the agency as evidence that the product is intended for use as a drug. For example, in its 2012 letters, FDA alleges that claims that a product “has the muscle-relaxing properties of Botox,” “can extend the results of a Botox injection,” or is “inspired by eye-lifting surgical techniques” cause a product to be a drug under the FDCA.[1]

Hair Restoration Claims

FDA also has taken the position that claims regarding hair restoration or loss prevention are drug claims. In 2012, FDA sent warning letters to personal care product companies alleging that claims that hair care products marketed as cosmetics could“stimulate hair growth,” “help revitalize hair,” or “combat…hair loss” caused the products to be misbranded drugs marketed in violation of the FDCA. Specifically, the letters alleged that the “products are not generally recognized as safe and effective for the above referenced uses; therefore the products are ‘new drugs’ as defined in section 201(p) of the Act,” and cannot be “legally marketed in the United States without an approved New Drug Application (NDA).”

Blemish Removal Claims

FDA’s 2012 letters also mark FDA’s intent to closely monitor claims that a product can improve the color or pigmentation of skin. In September 2012, FDA sent two letters to companies alleging that claims that their products could lighten “the scars in… upper arms,” remove acne scars, or “take.. away acne, rosacea, scars, skin blemishes and deep under skin lesions accumulated by excess UVA exposure,” “indicate[d] that these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body, rendering them drugs under the Act.”[2]

What It Means for You

As noted in our 2011 update, an unanticipated FDA warning letter can be costly for a company. FDA’s 2012 enforcement activity highlights some additional steps that can be taken by companies to limit the risk profile for personal care products as they are scrutinized by FDA.

• Continue to avoid product claims that imply physiological improvements to the body or hair. FDA’s 2012 warning letters reiterate the care with which claims must be made for personal care products. According to FDA, cosmetic products are intended to exert a physical but not physiological effect on the human body. Generally, claims which represent a product to have a physical effect, without causing the product to be a “drug,” include “moisturize,” “refresh,” “soften,” “clean,” and “deodorize.” Approved cosmetic claims also include claims that a product causes a body part to “appear” different (e.g., “makes lashes appear longer”). In contrast, such claims as “revitalize cells,” “restore hair growth,” and “remove scars” are believed by FDA to represent a product to have physiological effects on the structure or function of the body and, consequently, are reserved for “drug” products under FDA enforcement policies.

• Avoid comparing products to drugs or surgical procedures. FDA considers comparisons of personal care products to products recognized as drugs or medical procedures as evidence that the products are intended for use as drugs. Companies should establish guidelines encouraging marketing teams to avoid comparing cosmetic products to products regulated as drugs by FDA.

• Closely monitor testimonials provided on websites to ensure they do not contain drug claims. Many FDA warning letters stem from testimonials provided by consumers. Under FDA and FTC guidelines, marketers are responsible for claims made by endorsers and consumers on company sponsored websites. Companies should closely monitor their websites and other social media tools to ensure that products are not touted for uses FDA typically reserves for drugs.

FDA enforcement activity in 2012 indicates that FDA intends to assert its regulatory authority over personal care products. These steps can help to significantly reduce the risk profile for such products in 2013.

About the Author

Raqiyyah R. Pippins is an associate in the Advertising and Marketing and Food and Drug Law practices at Kelley Drye & Warren LLP in Washington, D.C. Contact her directly at rpippins@kelleydrye.com or learn more about the firm at www.kelleydrye.com.